BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193660 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41419
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A NO DELIVERY ALARM OCCURRED AFTER A BOLUS DELIVERY. THE CUSTOMER STATED THE ALARM OCCURS WHEN THERE IS LESS THAN 50 UNITS OF INSULIN REMAINING IN THE RESERVOIR. CUSTOMER'S BLOOD GLUCOSE WAS 267 MG/DL. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT DURING A FIXED PRIME. THE CUSTOMER ALSO STATED HER CANNULA WAS NOT BENT. THE CUSTOMER WAS ADVISED TO CHANGE HER INFUSION SET. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671553 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR